Composition and method for treating alcoholism and other substance addictions

Abstract

Disclosed are pharmaceutical compositions comprising a benzodiazepine, an alcohol aversive agent, and an abuse aversive agent, and methods of use in preventing alcohol or cocaine abuse.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Application No. 60 / 910,017, filed Apr. 4, 2007, and to U.S. Provisional Application No. 60 / 828,830, filed Oct. 10, 2006, each of which is incorporated by reference in its entirety.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT[0002]Not applicable.INTRODUCTION[0003]The National Institute on Alcohol Abuse and Alcoholism (NIAAA) most recently estimates that 19.4 million or 9.4% of adult Americans are affected by alcohol or other substance use disorders1. Alcoholism is estimated to cost our economy at least 148 billion dollars annually. Additionally, an estimated 18,000 people are killed in the US each year in automobile accidents involving motorists driving under the influence (DUI), which accounts for 39% of automobile-related fatalities, and 1,400,000 citations for DUI are issued annually. Alcoholism adversely impacts families of alcoholics in myriad ways. For example, ...

AI Technical Summary

Benefits of technology

[0006]Recently, disulfiram has been used in combination with naltrexone or acamprosate, two newer pharmacological agents approved for treatment of alcoholism. Naltrexone is an opioid-receptor antagonist approved for use in the treatment of alcohol dependence in conjunction with psychosocial interventions. Naltrexone is believed to work by blocking μ-opioid receptors, thereby reducing the reinforcing effects of alcohol, leading to reduced feelings of intoxication and fewer cravings. Acamprosate (calcium homotaurinate) is a structural analogue of y-aminobutyric acid (GABA), and is thought to decrease alcohol intake by affecting calcium channels and modifying transmission along GABA and glutamine pathways in the brain, which may result in decreased positive reinforcement of alcohol intake and decreased withdrawal cravings. However, studies examining the efficacy of disulfiram used in combination with naltrexone or acamprosate in the treatment of alcoholism demonstrate mixed results4-6.

[0009]In another aspect, the present invention provides a method of preventing alcohol consumption and reducing at least one symptom of alcohol withdrawal in a subject comprising administering to the subject the composition of the invention in an amount effective to reduce at least one symptom of alcohol withdrawal and to cause alcohol aversion.

Problems solved by technology

Alcoholism is estimated to cost our economy at least 148 billion dollars annually.

Alcoholism adversely impacts families of alcoholics in myriad ways.

For example, alcoholism is associated with increased incidence of domestic violence and poverty.

Offspring of women who consume alcohol during pregnancy are at risk for developing fetal alcohol syndrome.

Even when faced with loss of health, family, and livelihood from continued drinking, most alcoholics are simply unable to stop drinking, i.e. they are addicted to alcohol.

Failure to maintain sobriety leads to denial of treatment and premature death.

In addition to the psychological components of addiction, and the initial acute physical withdrawal symptoms (tremors, hallucinations, nausea), many patients suffer persistent symptoms of anxiety and insomnia, which makes continued sobriety very difficult to maintain.

However, its use and effectiveness have been limited because of poor compliance2-3.

Even minute amounts of alcohol are sufficient to produce an acute, unpleasant physical response, which can last from 30 minutes to several hours, and can occur up to two weeks following cessation of treatment with disulfiram.